Percutaneous filtration catheter for valve repair surgery and methods of use

ABSTRACT

A percutaneous filtration catheter used to entrap emboli from a patient&#39;s aorta and heart during cardiac surgery. The catheter has an elongate member, a proximal end, and a distal end. A balloon occluder is mounted on the distal end of the elongate member and an expandable filter is mounted on the elongate member distal the balloon occluder. Methods for using the devices are also disclosed herein.

This is a continuation of U.S. patent application Ser. No. 09/441,707,filed Nov. 16, 1999, now U.S. Pat. No. 6,287,321, which is acontinuation of U.S. application Ser. No. 09/170,359, now U.S. Pat. No.6,051,014, filed Oct. 13, 1998. All of the above patents andapplications are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to filter devices for placementin a blood vessel to capture embolic material, and more particularly toa catheter system having an associated filter for percutaneous placementin an aorta to entrap embolic material from the aorta and heart duringcardiac surgery.

BACKGROUND OF THE INVENTION

Stroke has become a major source of morbidity following coronary arterybypass and other cardiovascular surgeries, including valvular repair,septal defect repair, removal of atrial myxoma, aneurysm repair, andmyocardial drilling. Classic factors associated with an increasedpost-operative stroke rate are advanced age, severe left ventriculardysfunction, long standing diabetes, protracted cardiopulmonary bypasstime, severe perioperative hypotension, history of previous stroke, andbilateral carotid disease. Possible mechanisms of perioperative strokeinclude a reduction in cerebral blood flow through a stenoticextracranial or intracranial vessel, embolization of atheroscleroticdebris from an ulcerated carotid artery plaque or aortic plaque,embolization of post-infarction left ventricular mural thrombus oratrial thrombus, and embolization of air inadequately evacuated from theheart or aorta. In valvular repair surgery, manipulation of the heavilycalcific aortic or mitral valve may result in calcium dislodgment in theleft coronary artery or left ventricle, with subsequent embolization.Although atheromatous debris most frequently embolizes to the brain,other affected body sites include the spleen, kidney, pancreas, andgastrointestinal tract. Embolization of these peripheral organs can leadto tissue ischemia or death.

In addition to stroke, other factors, e.g., chest wall trauma,contributing to morbidity in cardiac surgeries often arise from the useof cardiopulmonary bypass for circulatory support and median sternotomy.Minimally invasive procedures using beating-heart and port-accessapproach have been developed to achieve aortic occlusion, cardioplegiadelivery, and left ventricular decompression to allow coronaryrevascularization and other cardiac procedures to be performed in a lessinvasive fashion.

A need therefore exists for less invasive devices and methods whichfacilitate aortic occlusion and/or cardioplegia delivery in cardiacsurgeries and provide an arterial filter for reducing a patient's riskof perioperative stroke.

SUMMARY OF THE INVENTION

The present invention provides a percutaneous filtration catheter havingthe ability to capture emboli, including atheromatous fragments, fat,myocardial tissue debris, and air. The catheter further includescapabilities to provide aortic occlusion and cardioplegia delivery incardiac surgeries, especially in heart valve repair.

In one embodiment, the catheter comprises an elongate member havingproximal and distal ends. The distal end has (1) a balloon occluderwhich communicates with a lumen carried by the elongate member, and (2)an expandable filter mounted on the elongate member distal to theballoon occluder. The balloon occluder and the expandable filter areoperated independently at the proximal end of the elongate member. Theexpandable filter typically has a proximal edge bonded circumferentiallyand continuously to the elongate member, and a distal edge which expandsradially outward on activation.

In another embodiment, the elongate member has a second lumen forinfusing fluid, such as cardioplegia solution. The expandable filter maycomprise an expansion frame, which may have an umbrella frame in oneembodiment (for construction, see Barbut et al., U.S. Pat. No.5,769,816, and Ambrisco et al., U.S. Ser. No. 09/070,660, bothincorporated herein by reference in their entirety) and an inflationseal in another embodiment (for construction, see Barbut et al., U.S.Pat. No. 5,769,816). Furthermore, in certain embodiments, the expandablefilter is operable by manipulating at least one pull string at theproximal end of the elongate member.

The present invention also provides methods for capturing embolicmaterial in cardiac surgeries, thereby protecting a patient fromneurologic complication due to embolization. The methods employ apercutaneous filtration catheter having an elongate member with proximaland distal ends, a balloon occluder mounted on the distal end of theelongate member, and an expandable filter mounted on the elongate memberdistal the balloon occluder. A percutaneous incision in a patient'speripheral artery, such as a femoral or brachial artery, is madefollowed by insertion of the elongate member through the incision. Inminimally invasive cardiac procedures, the percutaneous filtrationcatheter can be introduced percutaneously through a peripheral artery,or alternatively, through a minimal access port, often located in apatient's intercostal space, to the ascending aorta. The distal end ofthe catheter is then advanced into the ascending aorta. The filter isexpanded and positioned above the aortic valve to entrap embolicmaterial from flowing downstream to peripheral organs. The balloonoccluder is inflated to provide circulatory isolation of the heart andcoronary blood vessels from the peripheral vascular system. In theembodiment which includes a second lumen, the second lumen can be usedto (1) deliver cardioplegia solution upstream to the heart to arrestcardiac function, or (2) to carry a pressure monitor. After cardiacarrest is achieved and cardiopulmonary bypass is initiated forcirculatory support, a variety of cardiothoracic surgeries can then beperformed, including coronary artery bypass grafting, heart valverepair, septal defect repair, removal of atrial myxoma, aneurysm repair,and myocardial drilling.

It will be understood that are many advantages to using a percutaneousfiltration catheter as disclosed herein. For example, the catheterprovides (1) a percutaneous access for catheter insertion, obviating theneed for an extensive tissue incision, (2) aortic occlusion throughinflating a balloon occluder, thereby minimizing damage to the aorticwall and reducing the risk of emboli dislodgment as compared totraditional clamping, (3) a filter which entraps embolic material duringcardiac surgery, thereby reducing a patient's risk of strokeperioperatively, (4) cardioplegia delivery upstream to the heart forcardiac arrest, and (5) access for devices to be introduced through anintercostal incision in minimally invasive cardiac procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a percutaneous filtration catheter according a firstembodiment.

FIG. 2 depicts a percutaneous filtration catheter according to anotherembodiment, the catheter having a second lumen.

FIG. 3 depicts a percutaneous filtration catheter positioned in anascending aorta.

FIG. 4 depicts different access routes for entry of the percutaneousfiltration catheter for use in a patient.

DETAILED DESCRIPTION

The devices and methods disclosed herein can be used in patients whohave been identified as being at risk for embolization duringcardiothoracic surgeries, thereby reducing their perioperativecomplications and length of hospital stay. FIG. 1 depicts a percutaneousfiltration catheter according to one embodiment. The catheter haselongate member 1, distal end 2, and proximal end 3. Balloon occluder 5,which may comprise an elastomeric balloon, is mounted on elongate member1 and communicates with inflation lumen 6. Expandable filter 10 ismounted on elongate member 1 distal the balloon occluder and can beoperated by actuating mechanism 12 at the proximal end of the catheter.

FIG. 2 depicts another embodiment of a percutaneous filtration catheterhaving a second lumen. The catheter carries second lumen 20 in additionto lumen 6 which communicates with balloon occluder 5 and inflation port7 for inflating the balloon occluder. Second lumen 20 communicates withport 22 and can be used to infuse cardioplegia solution, aspirate fluidor air, and/or to house a pressure monitor. Filter 10, mounted onelongate member 1, has expansion frame 15 and can be actuated bymechanism 12 at proximal end 3 of the catheter.

The length of a percutaneous filtration catheter is generally between 20and 90 centimeters, preferably approximately 50 centimeters. The outerdiameter of the catheter is generally between 0.1 and 0.4 centimeters,preferably approximately 0.2 centimeters. The balloon occluder, wheninflated, will generally have a diameter between 1.0 and 5.0centimeters, more preferably between 2.0 and 4.0 centimeters. Thefilter, when expanded, will generally have a diameter between 1.0 and5.0 centimeters, more preferably between 2.0 and 4.0 centimeters. Theforegoing ranges are set forth solely for the purpose of illustratingtypical device dimensions. The actual dimensions of a device constructedaccording to the principles of the present invention may obviously varyoutside of the listed ranges without departing from those basicprinciples.

Methods of using the devices disclosed herein are illustrated in FIG. 3.After a small percutaneous incision is made in a patient's femoralartery, distal end 2 of the percutaneous catheter is introduced throughthe incision and advanced into the ascending aorta. Expandable filter 10is then expanded to entrap embolic material originating from the heartor the aorta, including air, atheromatous plague, tissue debris, fat, orthrombi. Balloon occluder 5 is inflated through its communicatinginflation lumen 6 to provide aortic occlusion for cardiopulmonarybypass. Cardiac arrest can be achieved by delivering cardioplegiasolution upstream to the heart through lumen 20 and port 22. Lumen 20and port 22 can also be used to place a pressure monitor or to aspiratefluid, blood, air, tissue, or plaque debris from the heart and theaorta. A surgeon then can proceed with various cardiothoracic surgeries.

FIG. 4 depicts different percutaneous entry sites for a percutaneousfiltration catheter. The catheter is generally inserted through apatient's femoral arteries. Right groin 30 and left groin 32 are commonpercutaneous incision sites for introducing elongate member 1 of thecatheter, shown here entering through left groin 32 in the left femoralartery and advanced to the ascending aorta. In some patients, however,the femoral arteries are not suitable for catheter manipulation due tosevere atherosclerosis. Alternatively, the catheter can be insertedthrough right antecubital area 34 or left antecubital area 36. Elongatemember 1 of the catheter is shown inserted through antecubital area 34and advanced through the right brachial artery and brachiocephalic trunkto enter the ascending aorta. After final placement of the catheter inthe ascending aorta, expandable filter 10 is expanded to entrap emboliand balloon occluder 5 is inflated to provide circulatory isolation ofthe heart and coronary blood vessels from the peripheral vascularsystem.

It will be understood that the devices disclosed herein are particularwell suited to application for valve repair surgeries because thesesurgeries are recognized to generate embolic material upstream of thesite of aortic blockage. According to McBride et al., Glenn's Thoracicand Cardiovascular Surgery, 6th Ed., Vol. II (1986), incorporated hereinby reference, median sternotomy is often the incision used for replacingthe aortic valve or any combination of valves in which the aortic valveis included. After venous cannulation of the right atrium, inferior venacava, or superior vena cava, arterial cannulation of the aorta isestablished for cardiopulmonary bypass using the percutaneous filtrationcatheter disclosed herein. The catheter is positioned in the ascendingaorta via femoral artery or brachial artery access. The balloonoccluder, or other impermeable dam, is deployed to isolate the heartfrom peripheral circulation. The filter is deployed upstream of theoccluder in order to capture calcified plaque from the aortic or mitralvalve. Oxygenated blood from a bypass machine is infused through thecatheter downstream of the occluder. Cardioplegia solution isadministered to the aortic root while the aortic valve is manuallyclosed by external pressure on the root of the aorta or directly intothe coronary ostia.

In aortic valve repair, the aorta is opened through a transverseincision approximately 1 to 1.5 centimeters above the right coronaryartery. The standard approach to mitral valve repair is often through anincision parallel to the intra-atrial groove into the left atrium. Afterthe heavily calcific or fibrotic valve is resected sufficiently topermit visualization of the left ventricular chamber, a sponge is oftenplaced in this cavity to enmesh any calcium that may fragment from theannulus during decalcification. A culture stick placed in the leftcoronary orifice prevents embolization of calcium into this vessel, andthe retractor providing exposure of the valve usually blocks the rightcoronary orifice. A prosthetic valve is sutured into the valvularannulus after the diseased native valve is removed. The aorta is thenclosed with two layers of sutures. Aortic occlusion and filtration isremoved, and the patient is taken off cardiopulmonary bypass.

Although the foregoing invention has, for purposes of clarity ofunderstanding, been described in some detail by way of illustration andexample, it will be obvious that certain changes and modifications maybe practiced which will still fall within the scope of the appendedclaim.

What is claimed is:
 1. A method far heart surgery, comprising the stepsof: inserting a catheter through an incision, the catheter having aballoon occluder and an expandable filter distal to the occluder, theexpandable filter opening in a distally-facing direction; advancing adistal end of the catheter into the ascending aorta; expanding thefilter; inflating the balloon occluder; and performing surgery on theheart.
 2. The method of claim 1, wherein the catheter comprises anelongate member having a proximal end and a distal end, and wherein theballoon occluder is mounted on a distal region of the elongate member,and the expandable filter is mounted on the elongate member distal theballoon occluder.
 3. The method of claim 1, wherein the incision is apercutaneous incision in a patient's femoral artery.
 4. The method ofclaim 1, wherein the incision is a percutaneous incision in a patient'sintercostal space.
 5. The method of claim 1, wherein the filter isoperable from the proximal end of the elongate member.
 6. The method ofclaim 1, wherein the surgery is heart valve repair.
 7. The method ofclaim 1, wherein the surgery is septal defect repair.
 8. The method ofclaim 1, wherein the expandable filter further comprises an expansionframe.
 9. The method of claim 8, wherein the expansion frame comprisesan umbrella frame.
 10. The method of claim 8, wherein the expansionframe comprises an inflation seal.
 11. The method of claim 1, whereinthe expandable filter is operable by manipulating at least one pullstring.
 12. The method of claim 1, wherein the expandable filter has aproximal edge bonded circumferentially and continuously to the elongatemember, and a distal edge which expands radially on activation.
 13. Themethod of claim 1, wherein the step of inflating the balloon occluder isperformed before the step of expanding the filter.